Advanced Solid TumorsPhase 1/2NCT04618393
A Study of EMB-02 in Participants With Advanced Solid Tumors
A Phase 1/2 study testing EMB-02 in people with Advanced Solid Tumors, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 10 sites in 3 countries.
Trial summary
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- EMB-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 11 Mar 2021to 21 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1
- Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease is measurable or evaluable per RECIST v1.1
- Archival tumor samples available for retrospective analysis or biopsy will be taken.
- ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3 Months
- Adequate organ function to participate in the trial.
- Recovery from adverse events (AEs) related to prior anticancer therapy.
- Highly effective contraception
Who cannot join
- Patients who have active autoimmune disease or history of autoimmune disease
- History of severe irAE.
- History of severe allergic reactions
- Use of systemic corticosteroids.
- Symptomatic central nervous system metastases.
- Patients with cardiac dysfunction
Show all 18Show fewer
- Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)
- Prior treatment with a LAG-3 inhibitor
- Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
- Prior organ or stem cell/bone marrow transplant.
- Concurrent malignancy < 5 years prior to entry.
- Patients with active infections.
- Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment
- Live virus vaccines < 30 days prior to screening
- Pregnant or breast-feeding females
- Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment
- Any other serious underlying medical conditions
- Abuse on alcohol, cannabis- derived products or other drugs
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
China5 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
HanDan Central Hospital
Handan, Hebei
SuiNing Central Hospital
Suining, Sichuan
The first Affiliated Hospital of Xiamen University
Xiamen, Fujian
HeNan Provincial People's Hospital
Zhengzhou, Henan
Australia3 sites
Monash Health
Clayton, Victoria, 3168
Peninsula & South Eastern Haematology & Oncology Group (PASO)
Frankston, Victoria, 3199
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500
United States2 sites
University of Colorado Health Medical Group
Colorado Springs, Colorado, 80909
Prisma Health-Upstate
Greenville, South Carolina, 29605
About this study
Official title: A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.
Read the detailed description
This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dos(s)e (RP2D[s]) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
- Conditions
- Advanced Solid Tumors
- Being tested
- EMB-02
- Keywords
- Phase I/II, Bispecific antibody, PD-1, LAG-3, EMB-02, Immuno-oncology, dose escalation, cohort expansion, Neoplasms, Neoplasm Metastasis, advanced solid tumor
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB-02Biological
EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.
| Study group | Role | What they receive |
|---|---|---|
| EMB-02 | Experimental | In Phase I part: participants enrolled in the different time will receive EMB-02 once weekly (IV) at different ascending dose levels.
In Phase II part: participants will receive EMB-02 once weekly (IV) at previously defined RP2D. Receives: Biological: EMB-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events as assessed by CTCAE V5.0
Incidence and severity of AE.
Measured: Screening up to follow-up (30 days after the last dose)
Incidence of serious adverse events (SAE)
Incidence of SAE.
Measured: Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions
Incidence of dose interruptions of EMB-02 during treatment as a measure of tolerability.
Measured: Screening up to follow-up (30 days after the last dose)
Dose intensity
Actual amount of drug taken by patients divided by the planned amount.
Measured: Screening up to follow-up (30 days after the last dose)
The incidence of DLTs during the first cycle of treatment.
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Measured: First infusion to the end of Cycle 1 (each cycle is 28 days)
Antitumor activity(Objective Response Rate (ORR)
Measured by RECIST 1.1, only applicable in Phase II part
Measured: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Secondary outcomes (10)
Area under the serum concentration-time curve (AUC) of EMB-02
Blood samples for serum PK analysis will be obtained (AUC).
Measured: Through treatment until EOT visit, expected average 6 months
Maximum serum concentration (Cmax) of EMB-02
Blood samples for serum PK analysis will be obtained (Cmax)
Measured: Through treatment until EOT visit, expected average 6 months
Trough concentration (Ctrough) of EMB-02
Blood samples for serum PK analysis will be obtained (Ctrough)
Measured: Through treatment until EOT visit, expected average 6 months
Average concentration over a dosing interval (Css, avg)of EMB-02.
Blood samples for serum PK analysis will be obtained (Css, avg).
Measured: Through treatment until EOT visit, expected average 6 months
Terminal half-life (T1/2) of EMB-02
Blood samples for serum PK analysis will be obtained (T1/2)
Measured: Through treatment until EOT visit, expected average 6 months.
Systemic clearance (CL) of EMB-02
Blood samples for serum PK analysis will be obtained (CL).
Measured: Through treatment until EOT visit, expected average 6 months
Steady state volume of distribution (Vss) of EMB-02
Blood samples for serum PK analysis will be obtained (Vss).
Measured: Through treatment until EOT visit, expected average 6 months
Progression free survival (PFS) of EMB-02 as assessed by RECIST 1.1
Preliminary anti-tumor activity of EMB-02 will be obtained (PFS).
Measured: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Duration of response of EMB-02 as assessed by RECIST 1.1
Preliminary anti-tumor activity of EMB-02 will be obtained (DOR).
Measured: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Incidence and titer of anti-drug antibodies stimulated by EMB-02
Antibodies to EMB-02 will be assessed to evaluate potential immunogenicity.
Measured: Up to End of Treatment Follow Up Period (30 days after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start11 Mar 2021
- Primary completion12 Jul 2023
- Study completion21 Mar 2024
Why it stopped: Company's resource optimization and product's development change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation followed by Cohort Expansion Phase at the RP2D.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618393
- Sponsor's protocol ID
- EMB02X101
- Status last verified
- May 2024
- First submitted
- 18 Oct 2020
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Day D, Ganju V, Chung K, Si L, Mao L, Aghmesheh M, Hoyer R, Brewin K, Zeng S, Zhang M, Lu Q, Jiang C, Ren F, Zhu Y, Guo J. First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors. Br J Cancer. 2025 Jun;132(10):905-912. doi: 10.1038/s41416-025-02990-x. Epub 2025 Apr 15.
PubMed 40234667Jiang C, Ren F, Zhang M, Lu Q, Zeng S, Yang G, Zhu Y. Using Pharmacokinetic and Pharmacodynamic Analysis to Optimize the Dosing Regimens of Fanastomig (EMB-02) in Patients With Advanced Solid Tumors. CPT Pharmacometrics Syst Pharmacol. 2025 May;14(5):975-986. doi: 10.1002/psp4.70011. Epub 2025 Mar 11.
PubMed 40067130
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04618393
- Acronym / sponsor ID
- EMB02X101
- Conditions
- Advanced Solid Tumors
- Keywords
- Phase I/II, Bispecific antibody, PD-1, LAG-3, EMB-02, Immuno-oncology, dose escalation, cohort expansion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company's resource optimization and product's development change
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.
Detailed description
This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dos(s)e (RP2D[s]) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation followed by Cohort Expansion Phase at the RP2D.
| Arm | Type | Receives |
|---|---|---|
| EMB-02 | Experimental | Biological: EMB-02In Phase I part: participants enrolled in the different time will receive EMB-02 once weekly (IV) at different ascending dose levels. In Phase II part: participants will receive EMB-02 once weekly (IV) at previously defined RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide written informed consent.
- Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1
- Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease is measurable or evaluable per RECIST v1.1
- Archival tumor samples available for retrospective analysis or biopsy will be taken.
- ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3 Months
Key exclusion criteria (18 listed)
- Patients who have active autoimmune disease or history of autoimmune disease
- History of severe irAE.
- History of severe allergic reactions
- Use of systemic corticosteroids.
- Symptomatic central nervous system metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMB-02EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3. | Biological | EMB-02 |
Primary outcome
Incidence and severity of adverse events as assessed by CTCAE V5.0
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence and severity of AE.
Incidence of serious adverse events (SAE)
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of SAE.
Incidence of dose interruptions
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions of EMB-02 during treatment as a measure of tolerability.
Dose intensity
Time frame: Screening up to follow-up (30 days after the last dose)
Actual amount of drug taken by patients divided by the planned amount.
The incidence of DLTs during the first cycle of treatment.
Time frame: First infusion to the end of Cycle 1 (each cycle is 28 days)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Antitumor activity(Objective Response Rate (ORR)
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Measured by RECIST 1.1, only applicable in Phase II part
10 secondary outcomes
Area under the serum concentration-time curve (AUC) of EMB-02
Time frame: Through treatment until EOT visit, expected average 6 months
Maximum serum concentration (Cmax) of EMB-02
Time frame: Through treatment until EOT visit, expected average 6 months
Trough concentration (Ctrough) of EMB-02
Time frame: Through treatment until EOT visit, expected average 6 months
Average concentration over a dosing interval (Css, avg)of EMB-02.
Time frame: Through treatment until EOT visit, expected average 6 months
Terminal half-life (T1/2) of EMB-02
Time frame: Through treatment until EOT visit, expected average 6 months.
Systemic clearance (CL) of EMB-02
Time frame: Through treatment until EOT visit, expected average 6 months
Steady state volume of distribution (Vss) of EMB-02
Time frame: Through treatment until EOT visit, expected average 6 months
Progression free survival (PFS) of EMB-02 as assessed by RECIST 1.1
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Duration of response of EMB-02 as assessed by RECIST 1.1
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Incidence and titer of anti-drug antibodies stimulated by EMB-02
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose)
Results and safety
The study was stopped early (reason given: Company's resource optimization and product's development change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 40234667Day D, Ganju V, Chung K, Si L, Mao L, Aghmesheh M, Hoyer R, Brewin K, Zeng S, Zhang M, Lu Q, Jiang C, Ren F, Zhu Y, Guo J. First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors. Br J Cancer. 2025 Jun;132(10):905-912. doi: 10.1038/s41416-025-02990-x. Epub 2025 Apr 15.
- Derived from this study: PubMed 40067130Jiang C, Ren F, Zhang M, Lu Q, Zeng S, Yang G, Zhu Y. Using Pharmacokinetic and Pharmacodynamic Analysis to Optimize the Dosing Regimens of Fanastomig (EMB-02) in Patients With Advanced Solid Tumors. CPT Pharmacometrics Syst Pharmacol. 2025 May;14(5):975-986. doi: 10.1002/psp4.70011. Epub 2025 Mar 11.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EMB-02 in people with Advanced Solid Tumors, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company's resource optimization and product's development change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events as assessed by CTCAE V5.0 (time frame: Screening up to follow-up (30 days after the last dose)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618393, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.